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The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and in Lithotripsy of stones.

It is indicated in medical specialties including, but not limited to:

• . Urology
• Gastroenterology
• Arthroscopy .
• . Neurosurgery
• Pulmonary .
• . Gynecology
• 0 ENT
• Dermatology 0
• Plastic Surgery ●
• General Surgery .

This Special 510(k) of the modified device Cyber Ho is submitted due to Device Modifications of the already cleared device Litho (K163009) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power, energy and frequency.

The provided text is a 510(k) Summary for the Cyber Ho laser system, detailing modifications made to an already cleared device, Litho (K163009). The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria for a diagnostic algorithm, a study proving device meeting acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.

Instead, the document details physical device modifications, regulatory compliance, and performance testing related to electrical safety, electromagnetic compatibility, and laser equipment standards.

Here's an analysis of what is present and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance:

• Not provided. The document does not include quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics typically associated with a diagnostic or AI algorithm. It only states that the device "successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards" and "passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. This information is relevant to studies involving patient data or images, which are not described here. The study here focuses on device engineering performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable/Not provided. This information is relevant to clinical studies where expert consensus is used to establish ground truth for a diagnostic algorithm. The document describes engineering and safety testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. This is relevant for clinical studies involving expert readers, which is not the type of study described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not provided/Not applicable. This document describes a laser surgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not provided. The device is a surgical laser system, not an algorithm, so "standalone algorithm performance" is not relevant in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable/Not provided. The "ground truth" in this context refers to compliance with established engineering and safety standards (e.g., electrical safety limits, EMC emission limits).

8. The sample size for the training set:

• Not applicable/Not provided. This pertains to machine learning algorithms, which are not the subject of this 510(k) submission.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. As above, this relates to machine learning.

Summary of what the document does provide regarding device performance and compliance:

The document describes the Cyber Ho laser system, which is a modification of a previously cleared device, Litho (K163009). The modifications include hardware and software changes, and a broadening of laser emission parameters (power, energy, frequency).

Performance Standards and Compliance (as described):

• No mandatory performance standards specific to this device type were identified, but the device underwent and passed testing according to the following recognized consensus standards:

  • IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • EN 60601-1-6:2010 + A1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
  • IEC 60601-2-22:2007+ A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • IEC 60825-1 Ed. 2.0 (2007) Safety of laser products - Part 1: Equipment classification and requirements

• Reported Device Performance (Qualitative):

  • "The device underwent and successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards."
  • "The modified device Cyber Ho passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

In essence, the study described in this 510(k) summary is an engineering and regulatory compliance study demonstrating that the modified device continues to meet established safety and performance requirements for medical electrical equipment and laser products, rather than a clinical study evaluating diagnostic accuracy or AI performance.

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